MAUDE Adverse Event Report: SMITH & NEPHEW WOUND MANAGEMENT RENASYS GO RENTAL DEVICE

Model Number 66800164R

Device Problems Fire (1245); Melted (1385); Device Emits Odor (1425); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/08/2014

Event Type  malfunction  

Event Description

Electrical short tissue viability nurse office, reported that renasys charger melted.She says charger had been flashing, she was alerted by a burning smell, and saw the charger alight in the wall.Charger melted.She unplugged charger.Denies accident related injury/home damage.

Event Description

(b)(6) reported that renasys charger melted.She says charger had been flashing, she was alerted by a burning smell, and saw the charger 'alight' in the wall.Charger melted.She unplugged charger.Denies accident related injury/home damage.

Manufacturer Narrative

Active investigation in progress; results of investigation will be provided in a supplement report.

• Brand Name: RENASYS GO RENTAL DEVICE
• Type of Device: RENASYS GO RENTAL DEVICE
• Manufacturer (Section D): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer (Section G): SMITH & NEPHEW WOUND MANAGEMENT; 970 lake carillon drive; suite 110; st. petersburg FL 33716
• Manufacturer Contact: terry mcmahon ; 970 lake carillon drive; suite 110; st. petersburg, FL 33716 ; 7273993785
• MDR Report Key: 4060864
• MDR Text Key: 5341098
• Report Number: 3006760724-2014-00405
• Device Sequence Number: 1
• Product Code: BTA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083375
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 66800164R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/11/2014
• Date Manufacturer Received: 08/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1